October 2015 FDA Recall Drug by Avantor Performance Materials Inc
D-0563-2016 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Avantor Performance Materials Inc on October 30, 2015 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Distributed in the US including: CA, IL & NC; Canada and the recall is currently terminated.

Recall Number: D-0563-2016

Reason for Recall
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Initiated
10-30-2015
Reported
01-13-2016
Quantity
265 Drums

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72818
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Avantor Performance Materials Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in the US including: CA, IL & NC; Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-19-2016
Product Description About Product Description
Full technical description of the product.
Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.

Batch or Lot Expiration Information

Lot# : 0000115590, Expiry: 5/10/17
Lot# : 0000117563, Expiry: 5/10/17.